The present invention is directed to an adjustable surgical support system for retaining and positioning the lower extremity of a patient during a surgical procedure. More specifically, the present invention relates to an adjustable surgical support system having a lower extremity support with a downwardly extending ball mount selectively insertable in and among one of a plurality of apertures formed in a base plate, for adjusting the position of the foot, lower leg and/or knee of a surgical patient laying in a supine position on an operating table during surgery (e.g., knee replacement).
Orthopedic surgery is the branch of surgery concerned with conditions involving the musculoskeletal system. Orthopaedic surgeons may use surgical, non-surgical or other minimally invasive procedures to treat musculoskeletal trauma, sports injuries, degenerative diseases, infections, tumors, etc. One particular area of orthopedic surgery concerns the knee joint, and includes surgical procedures such as total knee arthroscopy (“TKA”), partial knee arthroscopy, ligamentous reconstruction, cartilage reconstruction and fracture care. For example, the TKA procedure involves opening the knee (i.e., the surgical approach) and replacing worn out surfaces with new metal and/or plastic surfaces. Numerous devices such as mechanical instruments, computers and robots assist the surgeon in making the correct decisions and guiding the bone cuts. During these procedures (especially TKA), the knee must be securely positioned and supported in various orientations. Further to this point is that surgeons must move and reorient the knee into various positions of flexion during the surgery. This allows the surgeon to view different components of the knee and to ensure an optimum fit and function of the prosthesis.
A variety of support devices are known in the art for supporting the leg and foot while an anesthetized patient is laying in a supine position on an operating room table. These devices range from simple sand bags taped to the operating table to complex mechanical devices having multiple moving parts. The more complex support devices in particular permit positional adjustment of the foot, lower leg and/or knee during surgery. In this respect, these support devices are typically mounted via clamps or bars to a metal edge or rail of the operating table. Unfortunately, this creates an electrically conductive connection between the support device and the operating table. This can be particularly problematic when using electrocautery surgery devices. To mitigate the potential for current running through the patient during surgery, a ground is placed on the patient (e.g., on a gel pad). The problem occurs when current travels through the positioning device rather than the “ground” on the patient. This could result in electrical current passing through the patient, thereby causing burns or other injury. This is obviously highly undesirable, and could be avoided altogether if the positioning device does not form an electrically conductive connection to the operating table. Moreover, conventional adjustable support devices include moving parts that create needless wear and tear, complexity and pinch points. These devices can also undesirably constrain the rotation of the tibia relative to the femur.
For example, U.S. Pat. No. 8,302,228 to Aboujaoude discloses a lower extremity surgical positioning device that includes a foot assembly designed to support the lower leg and foot of a patient during surgery. More specifically, the Aboujaoude device includes the combination of an articulating and rotating frame or cradle that attaches to a foot assembly acting as a leg and foot splint firmly anchored or attached to the surgical table. The lower leg cradle securely attaches to the patient via a series of adjustable straps that wrap around the thigh, shin area, ankle, and foot of the patient. This is designed to prevent the extremity of the patient from moving independently of the cradle. The assembly securely affixes to a side rail on the operating table via a rail mounting clamp or rail mount. The rail mount connects to an operating table rail and is rotatable relative thereto. Once the extremity of the patient is securely attached to the lower leg cradle and foot assembly via the straps, the physician can manipulate the extremity. For example, Aboujaoude discloses a rack and gear configuration and multiple adjustable pivot points to lengthen and/or rotate various portions of the foot assembly, for purposes of aligning and/or compressing certain features of the foot, leg and/or knee, such as for setting a broken bone in the leg. The problem here is that the Aboujaoude positioning device includes several moving parts, which may create undesirable pinch points. Moreover, the direct attachment to the operating table (e.g., the rails) may allow for an electrically conductive connection between the patient and the operating table by virtue of being connected thereto. This is undesirable, as mentioned above.
The De Mayo Knee Positioner® sold by Imp® Innovative Medical Products, Inc. of 87 Spring Lane, Plainville, Conn. 06062 is a similar leg and knee positioning system that also includes a boot for receiving the lower leg and foot of the surgical patient. The system includes a base device having a rail that provides sliding guidance for a boot support coupled to a support clamp that selectively secures or otherwise attaches to the operating table through rotatable operation of a single lever clamp. The surgeon selectively controls flexion and extension of the knee by selectively unlocking and sliding the boot support in the rail along the length of the base. Like the Aboujaoude positioning device, the De Mayo Knee Positioner® includes pinch points within the rail and clamp areas and can create an electrically conductive connection between the patient and operating table potentially causing an undesirable “ground” for electrocautery or other electrical surgery devices. These features, as mentioned above, are highly undesirable.
Additionally, Innomed, Inc. of 103 Estus Drive, Savannah, Ga. 31404 manufactures and sells a series of knee and leg positioning products called the Robb Leg Positioner, Stulberg Leg Positioner and Stulberg Sliding Bolster, for use in knee surgeries. For instance, the Robb Leg Positioner includes a leg and foot support or cradle that includes a pair of outwardly projecting engagement cylinders that selectively rotatably engage one of a set of hooks formed from a base that sits or otherwise clamps to the operating table. A surgeon may flex or extend the knee during surgery by rotating the leg/foot support in a selected set of engaged hooks, or by selectively unhooking the engagement cylinders from one set of hooks and re-engaging the engagement cylinders in another set of hooks along the length of the base. The leg and foot support can pivot within the hooks around the central axis of the engagement cylinders. One drawback of the Robb Leg Positioner is that the exposed hooks are jagged and may undesirably snag gloves, clothing, or tools in the operating room. Furthermore, pinch points exist between the engagement cylinders and upstanding hooks, which could inadvertently slide out from engagement during a surgery. Additionally, the leg of the patient cannot be rotated and can only be located along a single plane, as opposed to laterally.
The Stulberg Leg Positioner is more closely related to the construction and operation of the Aboujaoude positioning device and the De Mayo Knee Positioner®, namely it is a leg and/or foot locking support mechanism that slides within a rail system integrated into a base, and can be locked thereto by a locking mechanism. Additionally, the Stulberg Sliding Bolster is basically a base plate attachable to an operating room table that includes a rail for providing sliding guidance of a foot bolster that can be locked relative thereto so the knee can be adjusted to different angles of knee flexion during surgery. These products include the same basic drawbacks discussed in more detail above related to moveable parts, pinch points and electrical conductivity between the patient and operating table.
The SPIDER2 Limb Positioner made by Smith & Nephew, Inc. of 150 Minuteman Road, Andover, Mass. 01810 is another leg positioning device known in the art that includes a plurality of movable joints or linkages that can be selectively engaged or disengaged through depression of a button or foot pedal. The SPIDER2 is complex, expensive and must remain powered at all times by a heavy battery pack attached at one end to operate. If the battery dies during surgery, this has obvious drawbacks since the device can no longer be repositioned during surgery. An electrically charged device can also be problematic in the event of a short or other electrical coupling of the device to the operating table and/or the patient.
There exist, therefore, a significant need in the art for an adjustable surgical support system that minimizes the number of moving components and otherwise eliminates any potential electrically conductive connection to the operating room table to prevent grounding of the device and conduction of electricity through the extremity of the patient resulting in burns, while permitting knee flexion and different amounts of medial or lateral movement of the foot relative to the hip. Such a system should include a lower extremity leg and/or foot support having a ball mount configured to be selectively received and/or repositioned within one of a plurality of conically shaped apertures in a base plate having a pair of channels at opposite ends thereof for selectively receiving a foot support attached to the operating table, thereby securing the base plate to the operating table while simultaneously electrically insulating the patient. The present invention fulfills these needs and provides other related advantages.